Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed. DoE is important for process development and validation as it offers […]

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization. Part of both ISO 13485 and QMS Internal audits are required as part […]

Preparing for an ISO 13485 audit

Being the current standard for medical devices; the ISO 13485 prescribes a set of standards that are to be implemented by manufacturers of medical devices. The aim of ISO 13485 is to ensure that medical devices meet the prescribed quality standards. This standard was conceived with the intention of making medical device manufacturers understand ways […]

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right. FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, […]

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “… a comprehensive and […]

Ensuring compliance with healthcare laws is of utmost importance for healthcare providers

Compliance with the many laws, as well as implementation of the necessary compliance initiatives are the means by which healthcare providers and entities or organizations involved in any type of healthcare transaction, especially those who bill or are involved with services payable by a CMS program, play a part in the protection of the integrity […]

Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees, who are the organization’s most important resource. It is through an HR audit that an organization evaluates its employees’ strengths and weaknesses. HR audits help organizations in a number of […]